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1. Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Author

EFSA Panel on Food Additives and Flavourings (FAF), Maged Younes, Gabriele Aquilina, Laurence Castle, Karl‐Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Ursula Gundert‐Remy, Trine Husøy, Wim Mennes, Peter Moldeus, Agneta Oskarsson, Sandra Rainieri, Romina Shah, Ine Waalkens‐Berendsen, Detlef Wölfle, Mona‐Lise Binderup, Claudia Bolognesi, Francesca Marcon, Daniel Marzin, Pasquale Mosesso, Maria Carfì, Giorgia Vianello, and Rainer Gürtler

Subjects
α,β‐unsaturated aldehydes, straight chain, FGE.200, flavouring substances, safety evaluation, subgroup 1.1.1, Nutrition. Foods and food supply, TX341-641, Chemical technology, TP1-1185
Abstract

Abstract The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.037] and 2‐nonenal [FL‐no: 05.171]. The Panel concluded that the concern still remains with respect to genotoxicity for the substances of this subgroup and requested an in vivo Comet assay performed in duodenum and liver for hex‐2(trans)‐enal [FL‐no: 05.073]. For the two other representative substances of subgroup 1.1.1 (nona‐2(trans),6(cis)‐dienal [FL‐no: 05.058] and oct‐2‐enal [FL‐no: 05.060]), the Panel requested a combined in vivo Comet assay and micronucleus assay. These data have been provided and are evaluated in the present opinion FGE.200 Rev1. Industry submitted genotoxicity studies on trans‐2‐octenal [FL‐no: 05.190], instead of oct‐2‐enal [FL‐no: 05.060]. Based on the available data, the Panel concluded that the concern for genotoxicity can be ruled out for hex‐2(trans)‐enal [FL‐no: 05.073], trans‐2‐octenal [FL‐no: 05.190] and nona‐2(trans),6(cis)‐dienal [FL‐no: 05.058], therefore all the 74 substances [FL‐no: 02.020, 02.049, 02.050, 02.090, 02.112, 02.137, 02.156, 02.192, 02.210, 02.231, 05.037, 05.058, 05.060, 05.070, 05.072, 05.073, 05.076, 05.078, 05.102, 05.109, 05.111, 05.114, 05.120, 05.144, 05.150, 05.171, 05.172, 05.179, 05.184, 05.189, 05.190, 05.191, 05.195, 06.025, 06.031, 06.072, 09.054, 09.097, 09.109, 09.119, 09.146, 09.233, 09.244, 09.247, 09.276, 09.277, 09.303, 09.312, 09.385, 09.394, 09.395, 09.396, 09.397, 09.398, 09.399, 09.400, 09.410, 09.411, 09.469, 09.482, 09.489, 09.492, 09.493, 09.498, 09.678, 09.701, 09.719, 09.741, 09.790, 09.841, 09.866, 09.947, 09.948, 13.004] can be evaluated through the Procedure for flavouring substances.

Published
2018
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2. Scientific Opinion on Flavouring Group Evaluation 200 (FGE.200): 74 α,β-unsaturated aldehydes and precursors from subgroup 1.1.1 of FGE.19

Author

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

Subjects
?, ?-unsaturated aldehydes, straight chain, FGE.200, flavouring substances, safety evaluation, subgroup 1.1.1, FGE.19, Nutrition. Foods and food supply, TX341-641, Chemical technology, TP1-1185
Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 (FGE.200). The Flavour Industry has provided additional genotoxicity studies for one representative substance in FGE.200, namely hex-2(trans)-enal [FL-no 05.073], and for other two substances in the same subgroup, namely 2-dodecenal [05.037] and 2-nonenal [05.171]. The Panel has evaluated these data and concluded that the concern still remains with respect to genotoxicity for the substances of this subgroup and their three representative substances. The Panel confirms, the need for an in vivo Comet assay performed in duodenum and liver for hex-2(trans)-enal [FL-no: 05.073]. For the two other representative substances of subgroup 1.1.1 (nona-2(trans),6(cis)-dienal [FL-no: 05.058] and oct-2-enal [FL-no: 05.060]), a combined in vivo Comet assay and micronucleus assay would be required. For the latter, evidence of bone marrow exposure should be provided.

Published
2014
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3. Scientific Opinion on Flavouring Group Evaluation 200 (FGE.200): 74 α,β- unsaturated aldehydes and precursors from subgroup 1.1.1 of FGE.19.

Subjects
*FLAVORING essences, *ALDEHYDES, *UNSATURATED compounds, *CHEMICAL precursors, *BONE marrow, *NUCLEOLUS
Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 (FGE.200). The Flavour Industry has provided additional genotoxicity studies for one representative substance in FGE.200, namely hex-2(trans)-enal [FL-no 05.073], and for other two substances in the same subgroup, namely 2-dodecenal [05.037] and 2-nonenal [05.171]. The Panel has evaluated these data and concluded that the concern still remains with respect to genotoxicity for the substances of this subgroup and their three representative substances. The Panel confirms, the need for an in vivo Comet assay performed in duodenum and liver for hex-2(trans)-enal [FL-no: 05.073]. For the two other representative substances of subgroup 1.1.1 (nona-2(trans),6(cis)-dienal [FL-no: 05.058] and oct-2-enal [FL-no: 05.060]), a combined in vivo Comet assay and micronucleus assay would be required. For the latter, evidence of bone marrow exposure should be provided. [ABSTRACT FROM AUTHOR]

Published
2014
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4. Scientific Opinion on Flavouring Group Evaluation 226 (FGE.226): Consideration of genotoxicity data on one α,β-unsaturated aldehyde from chemical subgroup 1.1.1(b) of FGE.19 by EFSA

Author

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

Subjects
5-Epoxydec-2(trans)-enal, Subgroup 1.1.1, FGE.19, FGE.200, FGE.226, Nutrition. Foods and food supply, TX341-641, Chemical technology, TP1-1185
Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of one flavouring substance from subgroup 1.1.1(b) of FGE.19 in the Flavouring Group Evaluation 226. The Flavour Industry has provided additional genotoxicity studies for the substance [FL-no: 16.071] in FGE.226. Based on these new data the Panel concluded that 4,5-epoxydec-2(trans)-enal did not induce gene mutations in bacterial cells but was positive in an in vitro micronucleus assay, so, 4,5-epoxydec-2(trans)-enal is considered an in vitro genotoxic agent. The negative results obtained in an in vivo micronucleus assay cannot overrule the positive results of the in vitro micronucleus assaywith and without S9-mix due to the lack of cytotoxicity in the bone marrow. On this basis, an in vivo Comet assay in rodents is recommended in order to verify possible genotoxic effects at the first site of contact (e.g., stomach/duodenum cells).

Published
2012
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5. Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Author

Trine Husøy, Pasquale Mosesso, Detlef Wölfle, Peter Moldeus, Romina Shah, Peter Fürst, Karl-Heinz Engel, Rainer Gürtler, Agneta Oskarsson, Claudia Bolognesi, Gabriele Aquilina, Giorgia Vianello, Laurence Castle, Ursula Gundert-Remy, Ine Waalkens-Berendsen, Mona-Lise Binderup, Maged Younes, Maria Jose Frutos Fernandez, Daniel Marzin, Paul Fowler, Maria Carfì, Wim Mennes, Francesca Marcon, Sandra Rainieri, and Flavourings (Faf)

Subjects
040301 veterinary sciences, Stereochemistry, Veterinary (miscellaneous), Group evaluation, TP1-1185, Plant Science, 010501 environmental sciences, 01 natural sciences, Microbiology, 0403 veterinary science, Straight chain, TX341-641, subgroup 1.1.1, 0105 earth and related environmental sciences, Food Ingredients and Packaging, Nutrition. Foods and food supply, Chemistry, Chemical technology, FGE.19, safety evaluation, 04 agricultural and veterinary sciences, straight chain, flavouring substances, FGE.200, Scientific Opinion, Animal Science and Zoology, Parasitology, α,β‐unsaturated aldehydes, Food Science
Abstract

The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.037] and 2‐nonenal [FL‐no: 05.171]. The Panel concluded that the concern still remains with respect to genotoxicity for the substances of this subgroup and requested an in vivo Comet assay performed in duodenum and liver for hex‐2(trans)‐enal [FL‐no: 05.073]. For the two other representative substances of subgroup 1.1.1 (nona‐2(trans),6(cis)‐dienal [FL‐no: 05.058] and oct‐2‐enal [FL‐no: 05.060]), the Panel requested a combined in vivo Comet assay and micronucleus assay. These data have been provided and are evaluated in the present opinion FGE.200 Rev1. Industry submitted genotoxicity studies on trans‐2‐octenal [FL‐no: 05.190], instead of oct‐2‐enal [FL‐no: 05.060]. Based on the available data, the Panel concluded that the concern for genotoxicity can be ruled out for hex‐2(trans)‐enal [FL‐no: 05.073], trans‐2‐octenal [FL‐no: 05.190] and nona‐2(trans),6(cis)‐dienal [FL‐no: 05.058], therefore all the 74 substances [FL‐no: 02.020, 02.049, 02.050, 02.090, 02.112, 02.137, 02.156, 02.192, 02.210, 02.231, 05.037, 05.058, 05.060, 05.070, 05.072, 05.073, 05.076, 05.078, 05.102, 05.109, 05.111, 05.114, 05.120, 05.144, 05.150, 05.171, 05.172, 05.179, 05.184, 05.189, 05.190, 05.191, 05.195, 06.025, 06.031, 06.072, 09.054, 09.097, 09.109, 09.119, 09.146, 09.233, 09.244, 09.247, 09.276, 09.277, 09.303, 09.312, 09.385, 09.394, 09.395, 09.396, 09.397, 09.398, 09.399, 09.400, 09.410, 09.411, 09.469, 09.482, 09.489, 09.492, 09.493, 09.498, 09.678, 09.701, 09.719, 09.741, 09.790, 09.841, 09.866, 09.947, 09.948, 13.004] can be evaluated through the Procedure for flavouring substances.

Published
2018

6. Scientific Opinion on Flavouring Group Evaluation 200 (FGE.200): 74 α,β-unsaturated aldehydes and precursors from subgroup 1.1.1 of FGE.19

Author

Karin Kristiane Nørby, Nathalie Georgette Jeanne GONTARD, European Food Safety Authority (EFSA), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Ingénierie des Agro-polymères et Technologies Émergentes (UMR IATE), Institut national d’études supérieures agronomiques de Montpellier (Montpellier SupAgro), and Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)-Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)-Centre de Coopération Internationale en Recherche Agronomique pour le Développement (Cirad)-Centre international d'études supérieures en sciences agronomiques (Montpellier SupAgro)-Université Montpellier 2 - Sciences et Techniques (UM2)-Université de Montpellier (UM)-Institut National de la Recherche Agronomique (INRA)

Subjects
Veterinary (miscellaneous), Group evaluation, Plant Science, TP1-1185, medicine.disease_cause, Microbiology, Straight chain, medicine, Organic chemistry, ?, [SPI.GPROC]Engineering Sciences [physics]/Chemical and Process Engineering, TX341-641, ?-unsaturated aldehydes, subgroup 1.1.1, ComputingMilieux_MISCELLANEOUS, 2. Zero hunger, Chemistry, business.industry, Nutrition. Foods and food supply, Chemical technology, FGE.19, safety evaluation, Food safety, straight chain, flavouring substances, FGE.200, Food packaging, Animal Science and Zoology, Parasitology, business, Genotoxicity, Food Science
Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 (FGE.200). The Flavour Industry has provided additional genotoxicity studies for one representative substance in FGE.200, namely hex-2(trans)-enal [FL-no 05.073], and for other two substances in the same subgroup, namely 2-dodecenal [05.037] and 2-nonenal [05.171]. The Panel has evaluated these data and concluded that the concern still remains with respect to genotoxicity for the substances of this subgroup and their three representative substances. The Panel confirms, the need for an in vivo Comet assay performed in duodenum and liver for hex-2(trans)-enal [FL-no: 05.073]. For the two other representative substances of subgroup 1.1.1 (nona-2(trans),6(cis)-dienal [FL-no: 05.058] and oct-2-enal [FL-no: 05.060]), a combined in vivo Comet assay and micronucleus assay would be required. For the latter, evidence of bone marrow exposure should be provided.

Published
2014

7. Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19.

Author

Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Engel, Karl‐Heinz, Fowler, Paul, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Husøy, Trine, Mennes, Wim, Moldeus, Peter, Oskarsson, Agneta, Rainieri, Sandra, Shah, Romina, Waalkens‐Berendsen, Ine, Wölfle, Detlef, Binderup, Mona‐Lise, Bolognesi, Claudia, Marcon, Francesca, and Marzin, Daniel

Subjects
*FOOD additives, *GENETIC toxicology, *CARBONYL compounds, *ALDEHYDES
Abstract

The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.037] and 2‐nonenal [FL‐no: 05.171]. The Panel concluded that the concern still remains with respect to genotoxicity for the substances of this subgroup and requested an in vivo Comet assay performed in duodenum and liver for hex‐2(trans)‐enal [FL‐no: 05.073]. For the two other representative substances of subgroup 1.1.1 (nona‐2(trans),6(cis)‐dienal [FL‐no: 05.058] and oct‐2‐enal [FL‐no: 05.060]), the Panel requested a combined in vivo Comet assay and micronucleus assay. These data have been provided and are evaluated in the present opinion FGE.200 Rev1. Industry submitted genotoxicity studies on trans‐2‐octenal [FL‐no: 05.190], instead of oct‐2‐enal [FL‐no: 05.060]. Based on the available data, the Panel concluded that the concern for genotoxicity can be ruled out for hex‐2(trans)‐enal [FL‐no: 05.073], trans‐2‐octenal [FL‐no: 05.190] and nona‐2(trans),6(cis)‐dienal [FL‐no: 05.058], therefore all the 74 substances [FL‐no: 02.020, 02.049, 02.050, 02.090, 02.112, 02.137, 02.156, 02.192, 02.210, 02.231, 05.037, 05.058, 05.060, 05.070, 05.072, 05.073, 05.076, 05.078, 05.102, 05.109, 05.111, 05.114, 05.120, 05.144, 05.150, 05.171, 05.172, 05.179, 05.184, 05.189, 05.190, 05.191, 05.195, 06.025, 06.031, 06.072, 09.054, 09.097, 09.109, 09.119, 09.146, 09.233, 09.244, 09.247, 09.276, 09.277, 09.303, 09.312, 09.385, 09.394, 09.395, 09.396, 09.397, 09.398, 09.399, 09.400, 09.410, 09.411, 09.469, 09.482, 09.489, 09.492, 09.493, 09.498, 09.678, 09.701, 09.719, 09.741, 09.790, 09.841, 09.866, 09.947, 09.948, 13.004] can be evaluated through the Procedure for flavouring substances. [ABSTRACT FROM AUTHOR]

Published
2018
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8. Scientific Opinion on Flavouring Group Evaluation 226 (FGE.226): Consideration of genotoxicity data on one α,β‐unsaturated aldehyde from chemical subgroup 1.1.1(b) of FGE.19 by EFSA

Author

Flavourings

Subjects
food.ingredient, Stereochemistry, Veterinary (miscellaneous), Group evaluation, TP1-1185, Plant Science, medicine.disease_cause, Microbiology, Aldehyde, food, FGE.226, medicine, TX341-641, Food science, chemistry.chemical_classification, Nutrition. Foods and food supply, Chemical technology, Food additive, FGE.19, FGE.200, 5-Epoxydec-2(trans)-enal, Food packaging, chemistry, Subgroup 1.1.1, Animal Science and Zoology, Parasitology, Genotoxicity, Food Science
Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of one flavouring substance from subgroup 1.1.1(b) of FGE.19 in the Flavouring Group Evaluation 226. The Flavour Industry has provided additional genotoxicity studies for the substance [FL-no: 16.071] in FGE.226. Based on these new data the Panel concluded that 4,5-epoxydec-2(trans)-enal did not induce gene mutations in bacterial cells but was positive in an in vitro micronucleus assay, so, 4,5-epoxydec-2(trans)-enal is considered an in vitro genotoxic agent. The negative results obtained in an in vivo micronucleus assay cannot overrule the positive results of the in vitro micronucleus assaywith and without S9-mix due to the lack of cytotoxicity in the bone marrow. On this basis, an in vivo Comet assay in rodents is recommended in order to verify possible genotoxic effects at the first site of contact (e.g., stomach/duodenum cells).

Published
2012

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